U.S. patent number 8,356,645 [Application Number 13/530,446] was granted by the patent office on 2013-01-22 for transfer guard systems and methods.
This patent grant is currently assigned to Medtronic MiniMed, Inc.. The grantee listed for this patent is Rafael Bikovsky, Colin A. Chong, Arsen Ibranyan, Julian D. Kavazov, Eric M. Lorenzen, Chad Srisathapat. Invention is credited to Rafael Bikovsky, Colin A. Chong, Arsen Ibranyan, Julian D. Kavazov, Eric M. Lorenzen, Chad Srisathapat.
United States Patent |
8,356,645 |
Chong , et al. |
January 22, 2013 |
Transfer guard systems and methods
Abstract
A transfer guard may provide a fluid path from a vial to a
reservoir containing a plunger head connected to a plunger arm
operatively engagable with a handle that at least partially covers
a casing configured to allow the handle to operatively engage the
plunger arm to move the plunger head to transfer fluidic media from
the vial to the reservoir. A support structure may have a chamber,
a first adapter for mating with a vial containing fluidic media,
and a second adapter for mating with a reservoir containing a
plunger head moveable within the reservoir. A first needle may
provide a fluid path from the vial to the reservoir and a second
needle may connect the vial and the chamber containing an air flow
control mechanism for allowing air to flow in one direction.
Inventors: |
Chong; Colin A. (Burbank,
CA), Kavazov; Julian D. (Arcadia, CA), Bikovsky;
Rafael (Oak Park, CA), Ibranyan; Arsen (Glendale,
CA), Lorenzen; Eric M. (Granada Hills, CA), Srisathapat;
Chad (Sun Valley, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Chong; Colin A.
Kavazov; Julian D.
Bikovsky; Rafael
Ibranyan; Arsen
Lorenzen; Eric M.
Srisathapat; Chad |
Burbank
Arcadia
Oak Park
Glendale
Granada Hills
Sun Valley |
CA
CA
CA
CA
CA
CA |
US
US
US
US
US
US |
|
|
Assignee: |
Medtronic MiniMed, Inc.
(Northridge, CA)
|
Family
ID: |
43063386 |
Appl.
No.: |
13/530,446 |
Filed: |
June 22, 2012 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20120289925 A1 |
Nov 15, 2012 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12537579 |
Aug 7, 2009 |
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Current U.S.
Class: |
141/329; 141/285;
141/2; 604/412 |
Current CPC
Class: |
A61M
5/1456 (20130101); A61J 1/2096 (20130101); A61M
5/14248 (20130101); A61J 1/2089 (20130101); A61J
1/2075 (20150501); A61J 1/201 (20150501); A61M
2005/14268 (20130101); Y10T 29/494 (20150115); A61J
1/2013 (20150501) |
Current International
Class: |
B65B
1/04 (20060101) |
Field of
Search: |
;141/285,301,319,329,330,2 ;604/412 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
US Non-Final OA, dtd Jun. 29, 2012 in related U.S. Appl. No.
12/537,579. cited by applicant .
US Non-Final Office Action dtd Aug. 27, 2012 in related U.S. Appl.
No. 12/537,579. cited by applicant.
|
Primary Examiner: Maust; Timothy L
Attorney, Agent or Firm: Foley & Lardner LLP
Parent Case Text
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
This application is a Divisional of U.S. application Ser. No.
12/537,579, filed Aug. 7, 2009, incorporated herein by reference in
its entirety.
Claims
What is claimed is:
1. A system for transferring fluidic media, the system comprising:
a support structure having a chamber, the support structure
comprising: a first adapter adapted to be mated to a vial having an
interior volume containing fluidic media; and a second adapter
adapted to be mated to a reservoir having an interior volume for
containing fluidic media and a plunger head arranged for movement
within the reservoir; a first needle for connecting the interior
volume of the vial to the interior volume of the reservoir to
provide a fluid flow path along a longitudinal dimension of the
support structure from the interior volume of the vial to the
interior volume of the reservoir; a second needle for connecting
the chamber and the interior volume of the vial; and an air flow
control mechanism arranged for movement within the chamber along
the longitudinal dimension of the support structure to selectively
allow air to flow in one direction in a case where the second
needle connects the chamber and the vial and the plunger head is
moved within the reservoir to transfer fluidic media through the
fluid flow path from the interior volume of the vial to the
interior volume of the reservoir.
2. The system of claim 1, the air flow control mechanism adapted to
allow the chamber to communicate with atmosphere to equalize
pressure relative to atmosphere in the interior volume of the vial
in a case where the second needle connects the chamber and the vial
and the plunger head is moved within the reservoir to transfer
fluidic media from the interior volume of the vial to the interior
volume of the reservoir.
3. The system of claim 1, wherein at least a portion of the first
needle is concentrically arranged within at least a portion of the
second needle.
4. The system of claim 3, wherein the first needle and the second
needle share a common axis.
5. The system of claim 3, wherein an axis of the first needle and
an axis of the second needle are parallel to each other; and
wherein the axis of the first needle is offset from the axis of the
second needle.
6. The system of claim 1, wherein the air flow control mechanism
comprises a valve.
7. The system of claim 6, wherein the air flow control mechanism
comprises at least one of an umbrella valve and a duckbill
valve.
8. The system of claim 6, the valve moveable at least between a
first position and a second position; the chamber for communicating
with atmosphere in a case where the valve is in the second position
and the fluid flow path is established.
9. The system of claim 1, the second adapter comprising a body
configured to envelop the reservoir.
10. The system of claim 9, the body adapted to allow fluidic media
in the reservoir to be viewable through the body in a case where
the reservoir is connected to the second adapter and the reservoir
contains fluidic media.
11. The system of claim 10, the body having an opening for allowing
fluidic media in the reservoir to be viewable and for allowing a
user-patient to provide further support to the reservoir during use
of the system.
12. The system of claim 9, the body having one or more fill lines
for measuring a volume of fluidic media in the reservoir.
13. The system of claim 1, wherein the airflow control mechanism is
enclosed completely within the chamber.
14. The system of claim 13, the airflow control mechanism having a
longitudinal dimension parallel with the longitudinal dimension of
the support structure; the airflow control mechanism having a first
surface opposite a second surface, the first surface and the second
surface aligned along the longitudinal dimension of the airflow
control mechanism; wherein the first surface faces the reservoir
when the reservoir is mated with the second adapter.
15. The system of claim 1, wherein the airflow control mechanism
includes a body having a channel extending through the body, the
channel for communicating between the chamber and atmosphere.
16. The system of claim 1, wherein the air flow control mechanism
is arranged for movement in a same direction as a direction in
which fluid is transferred from the vial to the reservoir.
17. The system of claim 1, wherein the air flow control mechanism
is arranged for movement in a direction toward the reservoir.
18. A method of making a system for transferring fluidic media, the
method comprising: supporting a support structure having a chamber,
the support structure comprising: a first adapter adapted to be
mated to a vial having an interior volume containing fluidic media;
and a second adapter adapted to be mated to a reservoir having an
interior volume for containing fluidic media and a plunger head
arranged for movement within the reservoir; connecting the interior
volume of the vial to the interior volume of the reservoir to
provide a fluid flow path along a longitudinal dimension of the
support structure from the interior volume of the vial to the
interior volume of the reservoir with a first needle; connecting
the chamber and the interior volume of the vial with a second
needle; and arranging an air flow control mechanism for movement
within the chamber along the longitudinal dimension of the support
structure the mechanism to selectively allow air to flow in one
direction to communicate with atmosphere in a case where the second
needle connects the chamber and the vial and the plunger head is
moved within the reservoir to transfer fluidic media through the
fluid flow path from the interior volume of the vial to the
interior volume of the reservoir.
19. The method of claim 18, further comprising adapting the air
flow control mechanism to allow the chamber to communicate with
atmosphere to equalize pressure relative to atmosphere in the
interior volume of the vial in a case where the second needle
connects the chamber and the vial and the plunger head is moved
within the reservoir to transfer fluidic media from the interior
volume of the vial to the interior volume of the reservoir.
20. The method of claim 18, further comprising concentrically
arranging at least a portion of the first needle within at least a
portion of the second needle.
21. The method of claim 18, wherein the first needle and the second
needle share a common axis.
22. The method of claim 18, wherein an axis of the first needle and
an axis of the second needle are parallel to each other; and
wherein the axis of the first needle is offset from the axis of the
second needle.
23. The method of claim 18, the second adapter comprising a body,
the method further comprising enveloping the reservoir with the
body of the second adapter.
24. The method of claim 18, further comprising configuring the body
to allow fluidic media in the reservoir to be viewable through the
body in a case where the reservoir is connected to the second
adapter and the reservoir contains fluidic media.
Description
BACKGROUND
1. Field of the Invention
Embodiments of the present invention generally relate to systems
and methods with reservoirs, and, in specific embodiments, to
systems and methods for assisted filling of reservoirs.
2. Related Art
According to modern medical techniques, certain chronic diseases
may be treated by delivering a medication or other substance to the
body of a patient. For example, diabetes is a chronic disease that
is commonly treated by delivering defined amounts of insulin to a
patient at appropriate times. Traditionally, manually operated
syringes and insulin pens have been employed for delivering insulin
to a patient. More recently, modern systems have been designed to
include programmable pumps for delivering controlled amounts of
medication to a patient.
Pump type delivery devices have been configured in external
devices, which connect to a patient, and have been configured in
implantable devices, which are implanted inside of the body of a
patient. External pump type delivery devices include devices
designed for use in a stationary location, such as a hospital, a
clinic, or the like, and further include devices configured for
ambulatory or portable use, such as devices designed to be carried
by a patient, or the like. External pump-type delivery devices may
contain reservoirs of fluidic media, such as, but is not limited
to, insulin.
External pump-type delivery devices may be connected in fluid flow
communication to a patient or user-patient, for example, through
suitable hollow tubing. The hollow tubing may be connected to a
hollow needle that is designed to pierce the skin of the patient
and to deliver fluidic media there through. Alternatively, the
hollow tubing may be connected directly to the patient as through a
cannula, or the like.
Examples of some external pump type delivery devices are described
in U.S. patent application Ser. No. 11/211,095, filed Aug. 23,
2005, titled "Infusion Device And Method With Disposable Portion"
and Published PCT Application WO 01/70307 (PCT/US01/09139) titled
"Exchangeable Electronic Cards For Infusion Devices" (each of which
is owned by the assignee of the present invention), Published PCT
Application WO 04/030716 (PCT/US2003/028769) titled "Components And
Methods For Patient Infusion Device," Published PCT Application WO
04/030717 (PCT/US2003/029019) titled "Dispenser Components And
Methods For Infusion Device," U.S. Patent Application Publication
No. 2005/0065760 titled "Method For Advising Patients Concerning
Doses Of Insulin," and U.S. Pat. No. 6,589,229 titled "Wearable
Self-Contained Drug Infusion Device," each of which is incorporated
herein by reference in its entirety.
External pump-type delivery devices may be connected in fluid-flow
communication to a patient-user, for example, through suitable
hollow tubing. The hollow tubing may be connected to a hollow
needle that is designed to pierce the patient-user's skin and
deliver an infusion medium to the patient-user. Alternatively, the
hollow tubing may be connected directly to the patient-user as or
through a cannula or set of micro-needles.
In contexts in which the hollow tubing is connected to the
patient-user through a hollow needle that pierces skin of the
user-patient, a manual insertion of the needle into the
patient-user can be somewhat traumatic to the user-patient.
Accordingly, insertion mechanisms have been made to assist the
insertion of a needle into the user-patient, whereby a needle is
forced by a spring to move quickly from a retracted position into
an extended position. As the needle is moved into the extended
position, the needle is quickly forced through the skin of the
user-patient in a single, relatively abrupt motion that can be less
traumatic to certain user-patients as compared to a slower, manual
insertion of a needle. While a quick thrust of the needle into the
skin of the user-patient may be less traumatic to some
user-patients than a manual insertion, it is believed that, in some
contexts, some user-patients may feel less trauma if the needle is
moved a very slow, steady pace.
Examples of insertion mechanisms that may be used with and may be
built into a delivery device are described in: U.S. patent
application Ser. No. 11/645,435, filed Dec. 26, 2006, titled
"Infusion Medium Delivery system, Device And Method With Needle
Inserter And Needle Inserter Device And Method,"; and U.S. patent
application Ser. No. 11/211,095, filed Aug. 23, 2005, titled
"Infusion Device And Method With Disposable Portion" (each of which
is assigned to the assignee of the present invention), each of
which is incorporated herein by reference in its entirety. Other
examples of insertion tools are described in U.S. Patent
Application Publication No. 2002/0022855, titled "Insertion Device
For An Insertion Set And Method Of Using The Same" (assigned to the
assignee of the present invention), which is incorporated herein by
reference in its entirety. Other examples of needle/cannula
insertion tools that may be used (or modified for use) to insert a
needle and/or cannula, are described in, for example U.S. patent
application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled
"Auto Insertion Device For Silhouette Or Similar Products," and/or
U.S. patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and
entitled "Insertion Device For Insertion Set and Method of Using
the Same," both of which are incorporated herein by reference in
their entirety.
Pump-type delivery devices can allow accurate doses of insulin to
be calculated and delivered automatically to a patient-user at any
time during the day or night. Furthermore, when used in conjunction
with glucose sensors or monitors, insulin pumps may be
automatically controlled to provide appropriate doses of infusion
medium at appropriate times of need, based on sensed or monitored
levels of blood glucose.
Pump-type delivery devices have become an important aspect of
modern medical treatments of various types of medical conditions,
such as diabetes. As pump technologies improve and as doctors and
patient-users become more familiar with such devices, the
popularity of external medical infusion pump treatment increases
and is expected to increase substantially over the next decade.
SUMMARY OF THE DISCLOSURE
A system for transferring fluidic media may include, but is not
limited to, a transfer guard, a handle, and a casing. The transfer
guard may be for providing a fluid path from a vial to a reservoir.
The handle may be configured to be operatively engagable to a
plunger arm connected to a plunger head arranged for movement in an
axial direction of the reservoir. The casing may be configured to
allow the plunger arm to move in the axial direction relative to
the reservoir to move the plunger head in the axial direction
within the reservoir. The handle may be configured to cover at
least a portion of the casing The transfer guard and the handle may
be configured such that fluidic media is transferred from the vial
to the reservoir in a case where the handle is operatively engaged
to the plunger arm and the handle is moved relative to the axial
direction relative to the reservoir.
In various embodiments, the casing may have an opening for allowing
the handle to operatively engage the plunger arm. In various
embodiments, the handle may include an engagement portion
configured for pivotal movement to operatively engage and disengage
the plunger arm. In some embodiments, the handle may include a
slide adapted to cause the pivotal movement of the engagement
portion to operatively engage and disengage the plunger arm. In
further embodiments, the slide may be adapted to move at least
between a first position and a second position. The engagement
portion may be configured to engage the plunger arm when the slide
is moved to the first position. The engagement portion may be
configured to disengage the plunger arm when the slide is moved to
the second position.
In some embodiments, the engagement portion may have an extension.
The plunger arm may have an aperture for receiving the extension
when the engagement portion of the handle operatively engages the
plunger arm. In further embodiments, the extension of the
engagement portion may be for extending through an opening in the
casing to operatively engage the aperture in the plunger arm and
for allowing the extension of the engagement portion to move along
the opening as the plunger arm is moved by the handle.
In various embodiments, the transfer guard may have an end for
mating with the reservoir. The end may comprise a body configured
to envelop the reservoir. In some embodiments, the body may be
adapted to allow fluidic media in the reservoir to be viewable
through the body in a case where the reservoir is connected to the
end of the transfer guard and the reservoir contains fluidic media.
In further embodiments, the body may have an opening for allowing
fluidic media in the reservoir to be viewable and for allowing a
user-patient to provide further support to the reservoir during use
of the system. In some embodiments, the body may have one or more
fill lines for measuring a volume of fluidic media in the
reservoir.
In various embodiments, the transfer guard may have a chamber. The
transfer guard may include, but is not limited to, a first needle,
a second needle, and an air flow control mechanism. The first
needle may be for connecting the interior volume of the vial to the
interior volume of the reservoir to provide a fluid flow path from
the interior volume of the vial to the interior volume of the
reservoir. The second needle may be for connecting the chamber and
the interior volume of the vial. The air flow control mechanism may
be arranged within the chamber and configured to allow air to flow
in one direction in a case where the second needle connects the
chamber and the vial and the plunger head is moved within the
reservoir to transfer fluidic media from the interior volume of the
vial to the interior volume of the reservoir.
In some embodiments, the air flow control mechanism may be
configured to allow the chamber to communicate with atmosphere to
equalize pressure relative to atmosphere in the interior volume of
the vial in a case where the second needle connects the chamber and
the vial and the plunger head is moved within the reservoir to
transfer fluidic media from the interior volume of the vial to the
interior volume of the reservoir. In some embodiments, the air flow
control mechanism may comprise a membrane configured to allow air
to flow in one direction. In some embodiments, the air flow control
mechanism may comprise a valve. In further embodiments, the valve
may comprise at least one of an umbrella valve and a duckbill valve
configured to allow air to flow in one direction.
A method of making a system for transferring fluidic media may
include, but is not limited to, any one of or combination of: (i)
providing a transfer guard for providing a fluid path from a vial
to a reservoir; (ii) configuring a handle to be operatively
engagable to a plunger arm connected to a plunger head arranged for
movement in an axial direction of the reservoir; (iii) configuring
a casing to allow the plunger arm to move in the axial direction
relative to the reservoir to move the plunger head in the axial
direction within the reservoir; (iv) configuring the handle to
cover at least a portion of the casing; and (v) configuring the
transfer guard and the handle such that fluidic media is
transferred from the vial to the reservoir in a case where the
handle is operatively engaged to the plunger arm and the handle is
moved in the axial direction relative to the reservoir.
A system for transferring fluidic media may include, but is not
limited to, a support structure, a first needle, a second needle,
and an air flow control mechanism. The support structure may have a
chamber. The support structure may include, but is not limited to a
first adapter and a second adapter. The first adapter may be
adapted to be mated to a vial having an interior volume containing
fluidic media. The second adapter may be adapted to be mated to a
reservoir having an interior volume for containing fluidic media
and a plunger head arranged for movement within the reservoir.
The first needle may be for connecting the interior volume of the
vial to the interior volume of the reservoir to provide a fluid
flow path from the interior volume of the vial to the interior
volume of the reservoir. The second needle may be for connecting
the chamber and the interior volume of the vial. The air flow
control mechanism may be arranged within the chamber and configured
to allow air to flow in one direction in a case where the second
needle connects the chamber and the vial and the plunger head is
moved within the reservoir to transfer fluidic media from the
interior volume of the vial to the interior volume of the
reservoir.
In various embodiments, at least a portion of the first needle may
be concentrically arranged within at least a portion of the second
needle. In some embodiments, the first needle and the second needle
may share a common axis. In some embodiments, an axis of the first
needle and an axis of the second needle may be parallel to each
other. The axis of the first needle may be offset from the axis of
the second needle.
In various embodiments, the air flow control mechanism may be
adapted to allow the chamber to communicate with atmosphere to
equalize pressure relative to atmosphere in the interior volume of
the vial in a case where the second needle connects the chamber and
the vial and the plunger head is moved within the reservoir to
transfer fluidic media from the interior volume of the vial to the
interior volume of the reservoir. In various embodiments, the air
flow control mechanism may comprise a membrane. In various
embodiments, the air flow control mechanism may comprise a valve.
In some embodiments, the air flow control mechanism may comprise at
least one of an umbrella valve and a duckbill valve. In some
embodiments, the valve may be moveable at least between a first
position and a second position. The chamber may be for
communicating with atmosphere in a case where the valve is in the
second position and the fluid flow path is established.
In various embodiments, the second adapter may comprise a body
configured to envelop the reservoir. In some embodiments, the body
may be adapted to allow fluidic media in the reservoir to be
viewable through the body in a case where the reservoir is
connected to the second adapter and the reservoir contains fluidic
media. In further embodiments, the body may have an opening for
allowing fluidic media in the reservoir to be viewable and for
allowing a user-patient to provide further support to the reservoir
during use of the system. In some embodiments, the body may have
one or more fill lines for measuring a volume of fluidic media in
the reservoir.
A method of making a system for transferring fluidic media may
include but is not limited to, any one of or combination of: (i)
supporting a support structure having a chamber, the support
structure comprising: a first adapter adapted to be mated to a vial
having an interior volume containing fluidic media; and a second
adapter adapted to be mated to a reservoir having an interior
volume for containing fluidic media and a plunger head arranged for
movement within the reservoir; (ii) connecting the interior volume
of the vial to the interior volume of the reservoir to provide a
fluid flow path from the interior volume of the vial to the
interior volume of the reservoir with a first needle; (iii)
connecting the chamber and the interior volume of the vial with a
second needle; and (iv) arranging an air flow control mechanism
within the chamber and configuring the air flow control mechanism
to allow air to flow in one direction in a case where the second
needle connects the chamber and the vial and the plunger head is
moved within the reservoir to transfer fluidic media from the
interior volume of the vial to the interior volume of the
reservoir.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a generalized representation of a system in
accordance with an embodiment of the present invention;
FIG. 2 illustrates an example of a system in accordance with an
embodiment of the present invention;
FIG. 3 illustrates an example of a delivery device in accordance
with an embodiment of the present invention;
FIG. 4 illustrates a delivery device in accordance with an
embodiment of the present invention;
FIG. 5A illustrates a durable portion of a delivery device in
accordance with an embodiment of the present invention;
FIG. 5B illustrates a section view of a durable portion of a
delivery device in accordance with an embodiment of the present
invention;
FIG. 5C illustrates a section view of a durable portion of a
delivery device in accordance with an embodiment of the present
invention;
FIG. 6A illustrates a disposable portion of a delivery device in
accordance with an embodiment of the present invention;
FIG. 6B illustrates a section view of a disposable portion of a
delivery device in accordance with an embodiment of the present
invention;
FIG. 6C illustrates a section view of a disposable portion of a
delivery device in accordance with an embodiment of the present
invention;
FIG. 7 is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 8A is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 8B is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 8C is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 9 illustrates a medical device in accordance with an
embodiment of the present invention;
FIG. 10 illustrates a portion of a medical device in accordance
with an embodiment of the present invention;
FIG. 11 illustrates a portion of a medical device in accordance
with an embodiment of the present invention;
FIG. 12 illustrates a portion of a medical device in accordance
with an embodiment of the present invention;
FIG. 13 is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 14A is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 14B is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 14C is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention;
FIG. 15 illustrates a flowchart for using a medical device in
accordance with an embodiment of the present invention;
FIG. 16A illustrates a portion of a medical device in accordance
with an embodiment of the present invention;
FIG. 16B illustrates a portion of a medical device in accordance
with an embodiment of the present invention; and
FIG. 17 is a cross-section of a portion of a medical device in
accordance with an embodiment of the present invention.
DETAILED DESCRIPTION
FIG. 1 illustrates a generalized representation of a system 10 in
accordance with an embodiment of the present invention. The system
10 includes a delivery device 12. The system 10 may further include
a sensing device 14, a command control device (CCD) 16, and a
computer 18. In various embodiments, the delivery device 12 and the
sensing device 14 may be secured at desired locations on the body 5
of a patient or user-patient 7. The locations at which the delivery
device 12 and the sensing device 14 are secured to the body 5 of
the user-patient 7 in FIG. 1 are provided only as representative,
non-limiting, examples.
The system 10, the delivery device 12, the sensing device 14, the
CCD 16, and computer 18 may be similar to those described in the
following U.S. patent applications that were assigned to the
assignee of the present invention, where each of following patent
applications is incorporated herein by reference in its entirety:
(i) U.S. patent application Ser. No. 11/211,095, filed Aug. 23,
2005, "Infusion Device And Method With Disposable Portion"; (ii)
U.S. patent application Ser. No. 11/515,225, filed Sep. 1, 2006,
"Infusion Medium Delivery Device And Method With Drive Device For
Driving Plunger In Reservoir"; (iii) U.S. patent application Ser.
No. 11/588,875, filed Oct. 27, 2006, "Systems And Methods Allowing
For Reservoir Filling And Infusion Medium Delivery"; (iv) U.S.
patent application Ser. No. 11/588,832, filed Oct. 27, 2006,
"Infusion Medium Delivery Device And Method With Drive Device For
Driving Plunger In Reservoir"; (v) U.S. patent application Ser. No.
11/588,847, filed Oct. 27, 2006, "Infusion Medium Delivery Device
And Method With Compressible Or Curved Reservoir Or Conduit"; (vi)
U.S. patent application Ser. No. 11/589,323, filed Oct. 27, 2006,
"Infusion Pumps And Methods And Delivery Devices And Methods With
Same"; (vii) U.S. patent application Ser. No. 11/602,173, filed
Nov. 20, 2006, "Systems And Methods Allowing For Reservoir Filling
And Infusion Medium Delivery"; (viii) U.S. patent application Ser.
No. 11/602,052, filed Nov. 20, 2006, "Systems And Methods Allowing
For Reservoir Filling And Infusion Medium Delivery"; (ix) U.S.
patent application Ser. No. 11/602,428, filed Nov. 20, 2006,
"Systems And Methods Allowing For Reservoir Filling And Infusion
Medium Delivery"; (x) U.S. patent application Ser. No. 11/602,113,
filed Nov. 20, 2006, "Systems And Methods Allowing For Reservoir
Filling And Infusion Medium Delivery"; (xi) U.S. patent application
Ser. No. 11/604,171, filed Nov. 22, 2006, "Infusion Medium Delivery
Device And Method With Drive Device For Driving Plunger In
Reservoir"; (xii) U.S. patent application Ser. No. 11/604,172,
filed Nov. 22, 2006, "Infusion Medium Delivery Device And Method
With Drive Device For Driving Plunger In Reservoir"; (xiii) U.S.
patent application Ser. No. 11/606,703, filed Nov. 30, 2006,
"Infusion Pumps And Methods And Delivery Devices And Methods With
Same"; (xiv) U.S. patent application Ser. No. 11/606,836, filed
Nov. 30, 2006, "Infusion Pumps And Methods And Delivery Devices And
Methods With Same"; U.S. patent application Ser. No. 11/636,384,
filed Dec. 8, 2006, "Infusion Medium Delivery Device And Method
With Compressible Or Curved Reservoir Or Conduit"; (xv) U.S. patent
application Ser. No. 11/645,993, filed Dec. 26, 2006, "Infusion
Medium Delivery Device And Method With Compressible Or Curved
Reservoir Or Conduit"; U.S. patent application Ser. No. 11/645,972,
filed Dec. 26, 2006, "Infusion Medium Delivery System, Device And
Method With Needle Inserter And Needle Inserter Device And Method";
(xvi) U.S. patent application Ser. No. 11/646,052, filed Dec. 26,
2006, "Infusion Medium Delivery System, Device And Method With
Needle Inserter And Needle Inserter Device And Method"; (xvii) U.S.
patent application Ser. No. 11/645,435, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; (xviii) U.S.
patent application Ser. No. 11/646,000, filed Dec. 26, 2006,
"Infusion Medium Delivery System, Device And Method With Needle
Inserter And Needle Inserter Device And Method"; (xix) U.S. patent
application Ser. No. 11/759,725, filed Jun. 7, 2007, "Infusion
Medium Delivery Device And Method With Drive Device For Driving
Plunger In Reservoir"; (xx) U.S. patent application Ser. No.
11/606,837, filed Nov. 30, 2006, "Method And Apparatus For
Enhancing The Integrity Of An Implantable Sensor Device"; (xxi)
U.S. patent application Ser. No. 11/702,713, filed Feb. 5, 2007,
"Selective Potting For Controlled Failure And Electronic Devices
Employing The Same"; (xxii) U.S. patent application Ser. No.
11/843,601, filed Aug. 22, 2007, "System And Method For Sensor
Recalibration"; (xxiii) U.S. patent application Ser. No.
11/868,898, filed Oct. 8, 2007, "Multilayer Substrate"; (xxiv) U.S.
patent application Ser. No. 11/964,649, filed Dec. 26, 2007,
"System And Methods Allowing For Reservoir Air Bubble Management";
(xxv) U.S. patent application Ser. No. 12/111,751, filed Apr. 29,
2008, "Systems And Methods For Reservoir Filling"; (xxvi) U.S.
patent application Ser. No. 12/111,815, filed Apr. 29, 2008,
"Systems And Methods For Reservoir Air Bubble Management"; (xxvii)
U.S. patent application Ser. No. 11/924,402, filed Oct. 25, 2007,
"Sensor Substrate And Method Of Fabricating Same"; (xxviii) U.S.
patent application Ser. No. 11/929,428, filed Oct. 30, 2007,
"Telemetry System And Method With Variable Parameters"; (xxix) U.S.
patent application Ser. No. 11/965,578, filed Dec. 27, 2007,
"Reservoir Pressure Equalization Systems And Methods"; (xxx) U.S.
patent application Ser. No. 12/107,580, filed Apr. 22, 2008,
"Automative Filling Systems And Methods"; (xxxi) U.S. patent
application Ser. No. 11/964,663, filed Dec. 26, 2007, "Medical
Device With Full Options And Selective Enablement/Disablement";
(xxxii) U.S. patent application Ser. No. 10/180,732, filed Jun. 26,
2002, "Communication Station And Software For Interfacing With An
Infusion Pump, Analyte Monitor, Analyte Meter, Or The Like";
(xxxiii) U.S. patent application Ser. No. 12/099,738, filed Apr. 8,
2008, "Systems And Methods Allowing For Reservoir Air Bubble
Management"; (xxxiv) U.S. patent application Ser. No. 12/027,963,
filed Feb. 7, 2008, "Adhesive Patch Systems And Methods"; (xxxv)
U.S. patent application Ser. No. 12/121,647, filed May 15, 2008,
"Multi-Lumen Catheter"; (xxxvi) U.S. Patent Provisional Application
Ser. No. 61/044,269, filed Apr. 11, 2008, "Reservoir Plunger Head
Systems And Methods"; (xxxvii) U.S. Patent Application Ser. No.
61/044,292, filed Apr. 11, 2008, "Reservoir Barrier Layer Systems
And Methods"; (xxxviii) U.S. Patent Provisional Application Ser.
No. 61/044,322, filed Apr. 11, 2008, "Reservoir Seal Retainer
Systems And Methods"; (xxxix) U.S. patent application Ser. No.
12/179,502, filed Jul. 24, 2008, "Method For Formulating And
Immobilizing A Matrix Protein And A Matrix Protein For Use In A
Sensor"; (xl) U.S. patent application Ser. No. 12/336,367, filed
Dec. 16, 2008, "Needle Insertions Systems And Methods"; (xli) U.S.
patent application Ser. No. 12/166,210, filed Jul. 1, 2008,
"Electronic Device For Controlled Failure"; (xlii) U.S. patent
application Ser. No. 12/271,134, filed Nov. 14, 2008, "Multilayer
Circuit Devices And Manufacturing Methods Using Electroplated
Sacrificial Structures"; (xliii) U.S. patent application Ser. No.
12/171,971, filed Jul. 11, 2008, "Infusion Medium Delivery System,
Device And Method With Needle Inserter And Needle Inserter Device
And Method"; (xliv) U.S. patent application Ser. No. 12/189,077,
filed Aug. 8, 2008, "Packaging System"; (xlv) U.S. patent
application Ser. No. 12/179,536, filed Jul. 24, 2008, "Real Time
Self-Adjusting Calibration Algorithm"; (xlvii) U.S. patent
application Ser. No. 12/277,186, filed Nov. 24, 2008, "Infusion
Medium Delivery System, Device And Method With Needle Inserter And
Needle Inserter Device And Method"; (xlviii) U.S. patent
application Ser. No. 12/211,783, filed Sep. 16, 2008, "Implantable
Sensor Method And System"; (xlix) U.S. patent application Ser. No.
12/247,945, filed Oct. 8, 2008, "Infusion Medium Delivery Device
And Method With Drive Device For Driving Plunger In Reservoir"; (l)
U.S. patent application Ser. No. 12/360,077, filed Jan. 26, 2009,
"Reservoir Barrier Layer Systems And Methods"; (li) U.S. patent
application Ser. No. 12/345,362, filed Dec. 29, 2008, "Reservoir
Seal Retainer Systems And Methods"; (lii) U.S. patent application
Ser. No. 12/353,181, filed Jan. 13, 2009, "Systems And Methods
Allowing For Reservoir Filling And Infusion Medium Delivery"; and
(liii) U.S. patent application Ser. No. 12/360,813, filed Jan. 27,
2009, "Multi-Position Infusion Set Device And Process." In other
embodiments, the system 10, delivery device 12, sensing device 14,
CCD 16, and computer 18 may have other suitable configurations.
The delivery device 12 may be configured to deliver fluidic media
to the body 5 of the user-patient 7. In various embodiments,
fluidic media may include a liquid, a fluid, a gel, or the like. In
some embodiments, fluidic media may include a medicine or a drug
for treating a disease or a medical condition. For example, fluidic
media may include insulin for treating diabetes, or may include a
drug for treating pain, cancer, a pulmonary disorder, HIV, or the
like. In some embodiments, fluidic media may include a nutritional
supplement, a dye, a tracing medium, a saline medium, a hydration
medium, or the like.
The sensing device 14 may include a sensor, a monitor, or the like,
for providing sensor data or monitor data. In various embodiments,
the sensing device 14 may be configured to sense a condition of the
user-patient 7. For example, the sensing device 14 may include
electronics and enzymes reactive to a biological condition, such as
a blood glucose level, or the like, of the user-patient 7.
In various embodiments, the sensing device 14 may be secured to the
body 5 of the user-patient 7 or embedded in the body 5 of the
user-patient 7 at a location that is remote from the location at
which the delivery device 12 is secured to the body 5 of the
user-patient 7. In various other embodiments, the sensing device 14
may be incorporated within the delivery device 12. In other
embodiments, the sensing device 14 may be separate and apart from
the delivery device, and may be, for example, part of the CCD 16.
In such embodiments, the sensing device 14 may be configured to
receive a biological sample, analyte, or the like, to measure a
condition of the user-patient 7.
In further embodiments, the sensing device 14 and/or the delivery
device 12 may utilize a closed-loop system. Examples of sensing
devices and/or delivery devices utilizing closed-loop systems may
be found at, but are not limited to, the following references: (i)
U.S. Pat. No. 6,088,608, entitled "Electrochemical Sensor And
Integrity Tests Therefor"; (ii) U.S. Pat. No. 6,119,028, entitled
"Implantable Enzyme-Based Monitoring Systems Having Improved
Longevity Due To Improved Exterior Surfaces"; (iii) U.S. Pat. No.
6,589,229, entitled "Implantable Enzyme-Based Monitoring Systems
Adapted for Long Term Use"; (iv) U.S. Pat. No. 6,740,072, entitled
"System And Method For Providing Closed Loop Infusion Formulation
Delivery"; (v) U.S. Pat. No. 6,827,702, entitled "Safety Limits For
Closed-Loop Infusion Pump Control"; (vi) U.S. Pat. No. 7,323,142,
entitled "Sensor Substrate And Method Of Fabricating Same"; (vii)
U.S. patent application Ser. No. 09/360,342, filed Jul. 22, 1999,
entitled "Substrate Sensor"; and (viii) U.S. Provisional Patent
Application Ser. No. 60/318,060, filed Sep. 7, 2001, entitled
"Sensing Apparatus and Process", all of which are incorporated
herein by reference in their entirety.
In such embodiments, the sensing device 14 may be configured to
sense a condition of the user-patient 7, such as, but not limited
to, blood glucose level, or the like. The delivery device 12 may be
configured to deliver fluidic media in response to the condition
sensed by the sensing device 14. In turn, the sensing device 14 may
continue to sense a new condition of the user-patient, allowing the
delivery device 12 to deliver fluidic media continuously in
response to the new condition sensed by the sensing device 14
indefinitely. In some embodiments, the sensing device 14 and/or the
delivery device 12 may be configured to utilize the closed-loop
system only for a portion of the day, for example only when the
user-patient is asleep or awake.
Each of the delivery device 12, the sensing device 14, the CCD 16,
and the computer 18 may include transmitter, receiver, or
transceiver electronics that allow for communication with other
components of the system 10. The sensing device 14 may be
configured to transmit sensor data or monitor data to the delivery
device 12. The sensing device 14 may also be configured to
communicate with the CCD 16. The delivery device 12 may include
electronics and software that are configured to analyze sensor data
and to deliver fluidic media to the body 5 of the user-patient 7
based on the sensor data and/or preprogrammed delivery
routines.
The CCD 16 and the computer 18 may include electronics and other
components configured to perform processing, delivery routine
storage, and to control the delivery device 12. By including
control functions in the CCD 16 and/or the computer 18, the
delivery device 12 may be made with more simplified electronics.
However, in some embodiments, the delivery device 12 may include
all control functions, and may operate without the CCD 16 and the
computer 18. In various embodiments, the CCD 16 may be a portable
electronic device. In addition, in various embodiments, the
delivery device 12 and/or the sensing device 14 may be configured
to transmit data to the CCD 16 and/or the computer 18 for display
or processing of the data by the CCD 16 and/or the computer 18.
In some embodiments, the sensing device 14 may be integrated into
the CCD 16. Such embodiments may allow the user-patient to monitor
a condition by providing, for example, a sample of his or her blood
to the sensing device 14 to assess his or her condition. In some
embodiments, the sensing device 14 and the CCD 16 may be for
determining glucose levels in the blood and/or body fluids of the
user-patient without the use of, or necessity of, a wire or cable
connection between the delivery device 12 and the sensing device 14
and/or the CCD 16.
In some embodiments, the CCD 16 may be for providing information to
the user-patient that facilitates the user-patient's subsequent use
of a drug delivery system. For example, the CCD 16 may provide
information to the user-patient to allow the user-patient to
determine the rate or dose of medication to be administered into
the body of the user-patient. In other embodiments, the CCD 16 may
provide information to the delivery device 12 to control the rate
or dose of medication administered into the body of the
user-patient
Examples of the types of communications and/or control
capabilities, as well as device feature sets and/or program options
may be found in the following references: (i) U.S. patent
application Ser. No. 10/445,477, filed May 27, 2003, entitled
"External Infusion Device with Remote Programming, Bolus Estimator
and/or Vibration Alarm Capabilities"; (ii) U.S. patent application
Ser. No. 10/429,385, filed May 5, 2003, entitled "Handheld Personal
Data Assistant (PDA) with a Medical Device and Method of Using the
Same"; and (iii) U.S. patent application Ser. No. 09/813,660, filed
Mar. 21, 2001, entitled "Control Tabs for Infusion Devices and
Methods of Using the Same," all of which are incorporated herein by
reference in their entirety.
FIG. 2 illustrates an example of the system 10 in accordance with
an embodiment of the present invention. The system 10 in accordance
with the embodiment illustrated in FIG. 2 includes the delivery
device 12 and the sensing device 14. The delivery device 12 in
accordance with an embodiment of the present invention includes a
disposable housing 20, a durable housing 30, and a reservoir system
40. The delivery device 12 may further include an infusion path
50.
Elements of the delivery device 12 that ordinarily contact the body
of a user-patient or that ordinarily contact fluidic media during
operation of the delivery device 12 may be considered as a
disposable portion of the delivery device 12. For example, a
disposable portion of the delivery device 12 may include the
disposable housing 20 and the reservoir system 40. The disposable
portion of the delivery device 12 may be recommended for disposal
after a specified number of uses.
On the other hand, elements of the delivery device 12 that do not
ordinarily contact the body of the user-patient or fluidic media
during operation of the delivery device 12 may be considered as a
durable portion of the delivery device 12. For example, a durable
portion of the delivery device 12 may include the durable housing
30, electronics (not shown in FIG. 2), a drive device having a
motor and drive linkage (not shown in FIG. 2), and the like.
Elements of the durable housing portion of the delivery device 12
are typically not contaminated from contact with the user-patient
or fluidic media during normal operation of the delivery device 12
and, thus, may be retained for re-use with replaced disposable
portions of the delivery device 12.
In various embodiments, the disposable housing 20 supports the
reservoir system 40 and has a bottom surface (facing downward and
into the page in FIG. 2) that is configured to secure to the body
of a user-patient. An adhesive may be employed at an interface
between the bottom surface of the disposable housing 20 and the
skin of a user-patient to adhere the disposable housing 20 to the
skin of the user-patient. In various embodiments, the adhesive may
be provided on the bottom surface of the disposable housing 20,
with a peelable cover layer covering the adhesive material. In this
manner, the cover layer may be peeled off to expose the adhesive
material, and the adhesive side of the disposable housing 20 may be
placed against the user-patient, for example against the skin of
the user-patient. Thus in some embodiments, the delivery device 12
may be attached to the skin of the user-patient.
In other embodiments, the disposable housing 20 and/or the
remaining portions of the delivery device 12 may be worn or
otherwise attached on or underneath clothing of the user-patient.
Similarly, the delivery device 12 may be supported by any suitable
manner, such as, but not limited to, on a belt, in a pocket, and
the like. Representative examples of such delivery devices 12 may
include, but is not limited to, the MiniMed Paradigm 522 Insulin
Pump, MiniMed Paradigm 722 Insulin Pump, MiniMed Paradigm 515
Insulin Pump, MiniMed Paradigm 715 Insulin Pump, MiniMed Paradigm
512R Insulin Pump, MiniMed Paradigm 712R Insulin Pump, MiniMed 508
Insulin Pump, MiniMed 508R Insulin Pump, and any other derivatives
thereof.
The reservoir system 40 is configured for containing or holding
fluidic media, such as, but not limited to insulin. In various
embodiments, the reservoir system 40 includes a hollow interior
volume for receiving fluidic media, such as, but not limited to, a
cylinder-shaped volume, a tubular-shaped volume, or the like. In
some embodiments, the reservoir system 40 may be provided as a
cartridge or canister for containing fluidic media. In various
embodiments, the reservoir system 40 is able to be refilled with
fluidic media. In further embodiments, the reservoir system 40 is
pre-filled with fluidic media.
The reservoir system 40 may be supported by the disposable housing
20 in any suitable manner. For example, the disposable housing 20
may be provided with projections or struts (not shown), or a trough
feature (not shown), for holding the reservoir system 40. In some
embodiments, the reservoir system 40 may be supported by the
disposable housing 20 in a manner that allows the reservoir system
40 to be removed from the disposable housing 20 and replaced with
another reservoir. Alternatively, or in addition, the reservoir
system 40 may be secured to the disposable housing 20 by a suitable
adhesive, a strap, or other coupling structure.
In various embodiments, the reservoir system 40 includes a port 41
for allowing fluidic media to flow into and/or flow out of the
interior volume of the reservoir system 40. In some embodiments,
the infusion path 50 includes a connector 56, a tube 54, and a
needle apparatus 52. The connector 56 of the infusion path 50 may
be connectable to the port 41 of the reservoir system 40. In
various embodiments, the disposable housing 20 is configured with
an opening near the port 41 of the reservoir system 40 for allowing
the connector 56 of the infusion path 50 to be selectively
connected to and disconnected from the port 41 of the reservoir
system 40.
In various embodiments, the port 41 of the reservoir system 40 is
covered with or supports a septum (not shown in FIG. 2), such as a
self-sealing septum, or the like. The septum may be configured to
prevent fluidic media from flowing out of the reservoir system 40
through the port 41 when the septum is not pierced. In addition, in
various embodiments, the connector 56 of the infusion path 50
includes a needle for piercing the septum covering the port 41 of
the reservoir system 40 to allow fluidic media to flow out of the
interior volume of the reservoir system 40.
Examples of needle/septum connectors can be found in U.S. patent
application Ser. No. 10/328,393, filed Dec. 22, 2003, entitled
"Reservoir Connector," which is incorporated herein by reference in
its entirety. In other alternatives, non-septum connectors such as
Luer locks, or the like may be used. In various embodiments, the
needle apparatus 52 of the infusion path 50 includes a needle that
is able to puncture the skin of a user-patient. In addition, in
various embodiments, the tube 54 connects the connector 56 with the
needle apparatus 52 and is hollow, such that the infusion path 50
is able to provide a path to allow for the delivery of fluidic
media from the reservoir system 40 to the body of a
user-patient.
The durable housing 30 of the delivery device 12 in accordance with
various embodiments of the present invention includes a housing
shell configured to mate with and secure to the disposable housing
20. The durable housing 30 and the disposable housing 20 may be
provided with correspondingly shaped grooves, notches, tabs, or
other suitable features, that allow the two parts to easily connect
together, by manually pressing the two housings together, by twist
or threaded connection, or other suitable manner of connecting the
parts that is well known in the mechanical arts.
In various embodiments, the durable housing 30 and the disposable
housing 20 may be connected to each other using a twist action. The
durable housing 30 and the disposable housing 20 may be configured
to be separable from each other when a sufficient force is applied
to disconnect the two housings from each other. For example, in
some embodiments the disposable housing 20 and the durable housing
30 may be snapped together by friction fitting. In various
embodiments, a suitable seal, such as an o-ring seal, may be placed
along a peripheral edge of the durable housing 30 and/or the
disposable housing 20, to provide a seal against water entering
between the durable housing 30 and the disposable housing 20.
The durable housing 30 of the delivery device 12 may support a
drive device (not shown in FIG. 2), including a motor and a drive
device linkage portion, for applying a force to fluidic media
within the reservoir system 40 to force fluidic media out of the
reservoir system 40 and into an infusion path, such as the infusion
path 50, for delivery to a user-patient. For example, in some
embodiments, an electrically driven motor may be mounted within the
durable housing 30 with appropriate linkage for operatively
coupling the motor to a plunger arm (not shown in FIG. 2) connected
to a plunger head (not shown in FIG. 2) that is within the
reservoir system 40 and to drive the plunger head in a direction to
force fluidic media out of the port 41 of the reservoir system 40
and to the user-patient.
Also, in some embodiments, the motor may be controllable to reverse
direction to move the plunger arm and the plunger head to cause
fluid to be drawn into the reservoir system 40 from a patient. The
motor may be arranged within the durable housing 30 and the
reservoir system 40 may be correspondingly arranged on the
disposable housing 20, such that the operable engagement of the
motor with the plunger head, through the appropriate linkage,
occurs automatically upon the user-patient connecting the durable
housing 30 with the disposable housing 20 of the delivery device
12. Further examples of linkage and control structures may be found
in U.S. patent application Ser. No. 09/813,660, filed Mar. 21,
2001, entitled "Control Tabs for Infusion Devices and Methods of
Using the Same", which is incorporated herein by reference in its
entirety.
In various embodiments, the durable housing 30 and the disposable
housing 20 may be made of suitably rigid materials that maintain
their shape, yet provide sufficient flexibility and resilience to
effectively connect together and disconnect, as described above.
The material of the disposable housing 20 may be selected for
suitable compatibility with skin. For example, the disposable
housing 20 and the durable housing 30 of the delivery device 12 may
be made of any suitable plastic, metal, composite material, or the
like. The disposable housing 20 may be made of the same type of
material or a different material relative to the durable housing
30. In some embodiments, the disposable housing 20 and the durable
housing 30 may be manufactured by injection molding or other
molding processes, machining processes, or combinations
thereof.
For example, the disposable housing 20 may be made of a relatively
flexible material, such as a flexible silicone, plastic, rubber,
synthetic rubber, or the like. By forming the disposable housing 20
of a material capable of flexing with the skin of a user-patient, a
greater level of user-patient comfort may be achieved when the
disposable housing 20 is secured to the skin of the user-patient.
In addition, a flexible disposable housing 20 may result in an
increase in site options on the body of the user-patient at which
the disposable housing 20 may be secured.
In the embodiment illustrated in FIG. 2, the delivery device 12 is
connected to the sensing device 14 through a connection element 17
of the sensing device 14. The sensing device 14 may include a
sensor 15 that includes any suitable biological or environmental
sensing device, depending upon a nature of a treatment to be
administered by the delivery device 12. For example, in the context
of delivering insulin to a diabetes patient, the sensor 15 may
include a blood glucose sensor, or the like.
In some embodiments, the sensor 15 may include a continuous glucose
sensor. The continuous glucose sensor may be implantable within the
body of the user-patient. In other embodiments, the continuous
glucose sensor may be located externally, for example on the skin
of the user-patient, or attached to clothing of the user-patient.
In such embodiments, fluid may be drawn continually from the
user-patient and sensed by the continuous glucose sensor. In
various embodiments, the continuous glucose sensor may be
configured to sense and/or communicate with the CCD 16
continuously. In other embodiments, the continuous glucose sensor
may be configured to sense and/or communicate with the CCD 16
intermittently, for example sense glucose levels and transmit
information every few minutes. In various embodiments, the
continuous glucose sensor may utilize glucose oxidase.
The sensor 15 may be an external sensor that secures to the skin of
a user-patient or, in other embodiments, may be an implantable
sensor that is located in an implant site within the body of the
user-patient. In further alternatives, the sensor may be included
with as a part or along side the infusion cannula and/or needle,
such as for example as shown in U.S. patent application Ser. No.
11/149,119, filed Jun. 8, 2005, entitled "Dual Insertion Set",
which is incorporated herein by reference in its entirety. In the
illustrated example of FIG. 2, the sensor 15 is an external sensor
having a disposable needle pad that includes a needle for piercing
the skin of the user-patient and enzymes and/or electronics
reactive to a biological condition, such as blood glucose level or
the like, of the user-patient. In this manner, the delivery device
12 may be provided with sensor data from the sensor 15 secured to
the user-patient at a site remote from the location at which the
delivery device 12 is secured to the user-patient.
While the embodiment shown in FIG. 2 includes a sensor 15 connected
by the connection element 17 for providing sensor data to sensor
electronics (not shown in FIG. 2) located within the durable
housing 30 of the delivery device 12, other embodiments may employ
a sensor 15 located within the delivery device 12. Yet other
embodiments may employ a sensor 15 having a transmitter for
communicating sensor data by a wireless communication link with
receiver electronics (not shown in FIG. 2) located within the
durable housing 30 of the delivery device 12. In various
embodiments, a wireless connection between the sensor 15 and the
receiver electronics within the durable housing 30 of the delivery
device 12 may include a radio frequency (RF) connection, an optical
connection, or another suitable wireless communication link.
Further embodiments need not employ the sensing device 14 and,
instead, may provide fluidic media delivery functions without the
use of sensor data.
As described above, by separating disposable elements of the
delivery device 12 from durable elements, the disposable elements
may be arranged on the disposable housing 20, while durable
elements may be arranged within a separable durable housing 30. In
this regard, after a prescribed number of uses of the delivery
device 12, the disposable housing 20 may be separated from the
durable housing 30, so that the disposable housing 20 may be
disposed of in a proper manner. The durable housing 30 may then be
mated with a new (un-used) disposable housing 20 for further
delivery operation with a user-patient.
FIG. 3 illustrates an example of the delivery device 12 in
accordance with another embodiment of the present invention. The
delivery device 12 of the embodiment of FIG. 3 is similar to the
delivery device 12 of the embodiment of FIG. 2. While the delivery
device 12 in the embodiment illustrated in FIG. 2 provides for the
durable housing 30 to cover the reservoir system 40, the delivery
device 12 in the embodiment of FIG. 3 provides for the durable
housing 30 to secure to the disposable housing 20 without covering
the reservoir system 40. The delivery device 12 of the embodiment
illustrated in FIG. 3 includes the disposable housing 20, and the
disposable housing 20 in accordance with the embodiment illustrated
in FIG. 3 includes a base 21 and a reservoir retaining portion 24.
In one embodiment, the base 21 and reservoir retaining portion 24
may be formed as a single, unitary structure.
The base 21 of the disposable housing 20 is configured to be
secured to the body of a user-patient. The reservoir retaining
portion 24 of the disposable housing 20 is configured to house the
reservoir system 40. The reservoir retaining portion 24 of the
disposable housing 20 may be configured to have an opening to allow
for the port 41 of the reservoir system 40 to be accessed from
outside of the reservoir retaining portion 24 while the reservoir
system 40 is housed in the reservoir retaining portion 24. The
durable housing 30 may be configured to be attachable to and
detachable from the base 21 of the disposable housing 20. The
delivery device 12 in the embodiment illustrated in FIG. 3 includes
a plunger arm 60 that is connected to or that is connectable to a
plunger head (not shown in FIG. 3) within the reservoir system
40.
FIG. 4 illustrates another view of the delivery device 12 of the
embodiment of FIG. 3. The delivery device 12 of the embodiment
illustrated in FIG. 4 includes the disposable housing 20, the
durable housing 30, and the infusion path 50. The disposable
housing 20 in the embodiment of FIG. 4 includes the base 21, the
reservoir retaining portion 24, and a peelable cover layer 25. The
peelable cover layer 25 may cover an adhesive material on the
bottom surface 22 of the base 21. The peelable cover layer 25 may
be configured to be peelable by a user-patient to expose the
adhesive material on the bottom surface 22 of the base 21. In some
embodiments, there may be multiple adhesive layers on the bottom
surface 22 of the base 21 that are separated by peelable
layers.
The infusion path 50 in accordance with the embodiment of the
present invention illustrated in FIG. 4 includes the needle 58
rather than the connector 56, the tube 54, and the needle apparatus
52 as shown in the embodiment of FIG. 2. The base 21 of the
disposable housing 20 may be provided with an opening or pierceable
wall in alignment with a tip of the needle 58, to allow the needle
58 to pass through the base 21 and into the skin of a user-patient
under the base 21, when extended. In this manner, the needle 58 may
be used to pierce the skin of the user-patient and deliver fluidic
media to the user-patient.
Alternatively, the needle 58 may be extended through a hollow
cannula (not shown in FIG. 4), such that upon piercing the skin of
the user-patient with the needle 58, an end of the hollow cannula
is guided through the skin of the user-patient by the needle 58.
Thereafter, the needle 58 may be removed, leaving the hollow
cannula in place, with one end of the cannula located within the
body of the user-patient and the other end of the cannula in fluid
flow connection with fluidic media within the reservoir system 40,
to convey pumped infusion media from the reservoir system 40 to the
body of the user-patient.
FIG. 5A illustrates a durable portion 8 of the delivery device 12
(refer to FIG. 3) in accordance with an embodiment of the present
invention. FIG. 5B illustrates a section view of the durable
portion 8 in accordance with an embodiment of the present
invention. FIG. 5C illustrates another section view of the durable
portion 8 in accordance with an embodiment of the present
invention. With reference to FIGS. 5A, 5B, and 5C, in various
embodiments, the durable portion 8 includes the durable housing 30,
and a drive device 80. The drive device 80 includes a motor 84 and
a drive device linkage portion 82.
In various embodiments, the durable housing 30 may include an
interior volume for housing the motor 84, the drive device linkage
portion 82, other electronic circuitry, and a power source (not
shown in FIGS. 5A, 5B, and 5C). In addition, in various
embodiments, the durable housing 30 is configured with an opening
32 for receiving a plunger arm 60 (refer to FIG. 3). In addition,
in various embodiments, the durable housing 30 may include one or
more connection members 34, such as tabs, insertion holes, or the
like, for connecting with the base 21 of the disposable housing 20
(refer to FIG. 3).
FIG. 6A illustrates a disposable portion 9 of the delivery device
12 (refer to FIG. 3) in accordance with an embodiment of the
present invention. FIG. 6B illustrates a section view of the
disposable portion 9 in accordance with an embodiment of the
present invention. FIG. 6C illustrates another section view of the
disposable portion 9 in accordance with an embodiment of the
present invention. With reference to FIGS. 6A, 6B, and 6C, in
various embodiments, the disposable portion 9 includes the
disposable housing 20, the reservoir system 40, the plunger arm 60,
and a plunger head 70. In some embodiments, the disposable housing
20 includes the base 21 and the reservoir retaining portion 24. In
various embodiments, the base 21 includes a top surface 23 having
one or more connection members 26, such as tabs, grooves, or the
like, for allowing connections with the one or more connection
members 34 of embodiments of the durable housing 30 (refer to FIG.
5B).
In various embodiments, the reservoir system 40 is housed within
the reservoir retaining portion 24 of the disposable housing 20,
and the reservoir system 40 is configured to hold fluidic media. In
addition, in various embodiments, the plunger head 70 is disposed
at least partially within the reservoir system 40 and is moveable
within the reservoir system 40 to allow fluidic media to fill into
the reservoir system 40 and to force fluidic media out of the
reservoir system 40. In some embodiments, the plunger arm 60 is
connected to or is connectable to the plunger head 70.
Also, in some embodiments, a portion of the plunger arm 60 extends
to outside of the reservoir retaining portion 24 of the disposable
housing 20. In various embodiments, the plunger arm 60 has a mating
portion for mating with the drive device linkage portion 82 of the
drive device 80 (refer to FIG. 5C). With reference to FIGS. 5C and
6C, in some embodiments, the durable housing 30 may be snap fitted
onto the disposable housing 20, whereupon the drive device linkage
portion 82 automatically engages the mating portion of the plunger
arm 60.
When the durable housing 30 and the disposable housing 20 are
fitted together with the drive device linkage portion 82 engaging
or mating with the plunger arm 60, the motor 84 may be controlled
to drive the drive device linkage portion 82 and, thus, move the
plunger arm 60 to cause the plunger head 70 to move within the
reservoir system 40. When the interior volume of the reservoir
system 40 is filled with fluidic media and an infusion path is
provided from the reservoir system 40 to the body of a
user-patient, the plunger head 70 may be moved within the reservoir
system 40 to force fluidic media from the reservoir system 40 and
into the infusion path, so as to deliver fluidic media to the body
of the user-patient.
In various embodiments, once the reservoir system 40 has been
sufficiently emptied or otherwise requires replacement, a
user-patient may simply remove the durable housing 30 from the
disposable housing 20, and replace the disposable portion 9,
including the reservoir system 40, with a new disposable portion
having a new reservoir. The durable housing 30 may be connected to
the new disposable housing of the new disposable portion, and the
delivery device including the new disposable portion may be secured
to the skin of a user-patient, or otherwise attached to the
user-patient.
In various other embodiments, rather than replacing the entire
disposable portion 9 every time the reservoir system 40 is emptied,
the reservoir system 40 may be refilled with fluidic media. In some
embodiments, the reservoir system 40 may be refilled while
remaining within the reservoir retaining portion 24 (refer to FIG.
6B) of the disposable housing 20. In addition, in various
embodiments, the reservoir system 40 may be replaced with a new
reservoir (not shown), while the disposable housing 20 may be
re-used with the new reservoir. In such embodiments, the new
reservoir may be inserted into the disposable portion 9.
With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments,
the delivery device 12 includes reservoir status circuitry (not
shown), and the reservoir system 40 includes reservoir circuitry
(not shown). In various embodiments, the reservoir circuitry stores
information such as, but not limited to, at least one of (i) an
identification string identifying the reservoir system 40; (ii) a
manufacturer of the reservoir system 40; (iii) contents of the
reservoir system 40; and (iv) an amount of contents in the
reservoir system 40. In some embodiments, the delivery device 12
includes the reservoir status circuitry (not shown), and the
reservoir status circuitry is configured to read data from the
reservoir circuitry when the reservoir system 40 is inserted into
the disposable portion 9.
In various embodiments, the reservoir status circuitry is further
configured to store data to the reservoir circuitry after at least
some of the contents of the reservoir system 40 have been
transferred out of the reservoir system 40, so as to update
information in the reservoir circuitry related to an amount of
contents still remaining in the reservoir system 40. In some
embodiments, the reservoir status circuitry is configured to store
data to the reservoir circuitry, to update information in the
reservoir circuitry related to an amount of contents remaining in
the reservoir system 40, when the reservoir system 40 is inserted
into the disposable portion 9. In some embodiments, the delivery
device 12 includes the reservoir status circuitry (not shown) and
the reservoir system 40 includes the reservoir circuitry (not
shown), and the reservoir status circuitry selectively inhibits use
of the delivery device 12 or selectively provides a warning signal
based on information read by the reservoir status circuitry from
the reservoir circuitry.
FIGS. 7-8C illustrate a system 100 for transferring fluidic media
in accordance with an embodiment of the present invention. The
system 100 may include features similar to, employed as an
embodiment of, and/or used with the medical device systems
discussed throughout the disclosure (e.g., delivery device 12 in
FIGS. 1-6C). Although the system 100 may include features similar
or used with the embodiments of FIGS. 1-6C, it should be understood
that the system 100 may also include some or all of the same
features and operate in a manner similar to that shown and
described in the embodiments of FIGS. 9-17. In addition, some or
all of the features shown in FIGS. 1-6C and 9-17 may be combined in
various ways and included in the embodiments shown in FIGS. 7-8C.
Likewise, it should be understood that any of the features of the
embodiments of FIGS. 7-8C may be combined or otherwise incorporated
into any of the other embodiments of FIGS. 7-8C as well as any
other embodiment herein discussed.
The system 100 may include, but is not limited to, a vial 140, a
transfer guard 160, and a reservoir 180. The vial 140 may include a
septum 144 located at a port 142 of the vial 140. The vial 140 may
have an interior volume 145 for containing fluidic media. The
reservoir 180 may have an interior volume 185 for containing
fluidic media. The reservoir 180 may include a septum 184 located
at a port 182 of the reservoir 180.
The plunger head 190 may be located within the reservoir 180 and
may be moveable within the reservoir 180 to expand or contract the
interior volume 185 of the reservoir 180. The plunger head 190 may
be attached to or integrated with the plunger arm 110. The handle
130 may be operatively to the plunger arm 110.
The plunger head 190 may include at least one seal member 199, such
as an o-ring, or the like, in contact with the reservoir 180. The
interior volume 185 of the reservoir body 180 may be on one side of
the seal member 199. The reservoir 180 may have a chamber 187
located on an opposite side of the seal member 199 from the
interior volume 185 of the reservoir 180. The seal member 199 may
be for facilitating movement within the reservoir 180 and/or to
substantially prevent fluidic media from flowing from the interior
volume 185 to the chamber 187 of the reservoir 180.
The transfer guard 160 may include a needle 152 for providing a
fluid path from the interior volume 145 of the vial 140 to the
interior volume 185 of the reservoir 180. The transfer guard 160
may be configured such that when the vial 140 is attached or
otherwise mated to the transfer guard 160, the needle 152 pierces
the septum 144 of the vial 140. The transfer guard 160 may be
further configured such that when the reservoir 180 is attached or
otherwise mated to the transfer guard 160, the needle 152 pierces
the septum 184 of the reservoir 180. Thus, the transfer guard 160
may allow for establishing a fluid path from the vial 140 to the
reservoir 180 through the needle 152.
In some embodiments, the transfer guard 160 may include a second
needle 156. The second needle 156 may be able to pierce the septum
144 of the vial 140 when the vial 140 is connected to the transfer
guard 160. An end of the second needle 156 may be located within a
headspace 147 of the vial 140 above fluidic media within the
interior volume 145 of the vial 140 in a case where the transfer
guard 160 is connected to the vial 140. In other embodiments, the
end of the second needle 156 may be in contact with fluidic media
within the interior volume 145 of the vial 140 in a case where the
transfer guard 160 is connected to the vial 140.
Another end of the second needle 156 may be connected to a check
valve 154, such as a one-way valve, or the like. The check valve
154 may allow air to enter the interior volume 145 of the vial 140
through the second needle 156. In some embodiments, the check valve
154 may substantially prevent liquid from coming out of the vial
140 through the second needle 156 and/or the check valve 154. In
various embodiments, the second needle 156 may allow for venting
the headspace 147 or the interior volume 145 of the vial 140 to
atmosphere to facilitate the transfer of fluidic media from the
vial 140 to the reservoir 180.
The transfer guard 160 may have a body 165, a first end 162, and a
second end 170. The first end 162 may be for supporting or
otherwise receiving the vial 140 to attach or otherwise mate with
the vial 140 to the transfer guard 160. For example, a portion of
the vial 140 (e.g., portion corresponding to the port 142 of the
vial 140) may be placed in the first end 162 of the transfer guard
160. As described above, the septum 144 of the vial 140 may be
pierced by the needle 152 of the transfer guard 160 when the vial
140 is inserted into the first end 162 of the transfer guard
160.
In some embodiments, the first end 162 may be adapted to secure the
vial 140 to the transfer guard 160 in any suitable manner known in
the art, such as (but not limited to) friction fitting,
snap-fitting, or the like. For example, the first end 162 of the
transfer guard 160 may include at least one tab 163, annular rib,
or the like for securing the vial 140 within the first end 162 of
the transfer guard 160 once the vial 140 is inserted in the first
end 162 of the transfer guard 160.
The second end 170 may be located opposite the first end 162. The
second end 170 may be for supporting or otherwise receiving the
reservoir 180 to attach or otherwise mate with the reservoir 180 to
the transfer guard 160. For example, a portion of the reservoir 180
(e.g., portion corresponding to the port 182 of the reservoir 180)
may be placed in the second end 170 of the transfer guard 160. The
septum 184 of the reservoir 180 may be pierced by the needle 152 of
the transfer guard 160 when the reservoir 180 is inserted into the
second end 170 of the transfer guard 160.
In some embodiments, the second end 170 may be adapted to secure
the reservoir 180 to the transfer guard 160 in any suitable manner
known in the art, such as (but not limited to) friction fitting,
snap-fitting, or the like. For example, as shown in FIGS. 7 and
8A-8C, the second end 170 of the transfer guard 160 may include one
or more depressions or apertures 171 located within the second end
170 of the transfer guard 160. The port 182 portion of the
reservoir 180 may include one or more tabs 186 for inserting into
the one or more apertures 171 located in the second end 170 of the
transfer guard 160. The port 182 portion of the reservoir 180 may
further include at least one second tab 188 attached to each of the
one or more tabs 186.
In some embodiments, the reservoir 180 and port 182 portion may be
configured, for example, to be rotatable, at least partially, about
the second end 170 of the transfer guard 160 to secure the
reservoir 180 to the transfer guard 160. The second end 170 of the
transfer guard 160 may further include one or more depressions 172
for receiving the at least one second tab 188 when the reservoir
180 and port 182 portion are rotated to secure the reservoir 180 to
the transfer guard 160. As a result, the port 182 portion of the
reservoir 180 may be inserted into the second end 170 of the
transfer guard 160 so that the one or more tabs 186 fit into the
apertures 171 and then rotated slightly until the at least one
second tab 188 fits into place within the one or more depressions
172 to lock the reservoir 180 into the second end 170 of the
transfer guard 160.
In some embodiments, the first end 162 and the vial 140 may be
configured in the same manner as described above so that the one or
more tabs 186 fit into the one or more apertures 171 and adapted to
be rotatable slightly until the at least one second tab 188 fits
into place within the one or more depressions 172. In some
embodiments, the second end 170 of the transfer guard 160 may be
configured to include at least one tab 163 for securing at least a
portion of the reservoir 180 within the second end 170 of the
transfer guard 160 similar to that described above with respect to
the first end 162 of the transfer guard 160.
FIGS. 9-17 illustrates a system 200 for transferring fluidic media
in accordance with an embodiment of the present invention. The
system 200 may include features similar to, employed as an
embodiment of, and/or used with the medical device systems
discussed throughout the disclosure (e.g., delivery device 12 in
FIGS. 1-6C). In addition, the system 200 may include features
similar to the systems discussed throughout the disclosure or
employed as an embodiments of the systems (e.g., system 100 in
FIGS. 7-8C) discussed throughout the disclosure. In addition, some
or all of the features shown in FIGS. 1-8C may be combined in
various ways and included in the embodiments shown in FIG. 9-17.
Likewise, it should be understood that any of the features of the
embodiments of FIGS. 9-17 may be combined or otherwise incorporated
into any of the other embodiments of FIGS. 9-17 as well as any
other embodiment herein discussed.
In particular embodiments, the system 200 may be similar to the
system 100 described with respect to FIGS. 7-8C. As shown, for
example in FIGS. 9 and 10, the system 200 may include, but is not
limited to, a vial 240, a transfer guard 260, a reservoir 280, a
plunger head 290, a plunger arm 210, a plunger arm casing 230, and
a handle 220.
FIGS. 11-14B illustrate a reservoir 280, which may include features
similar to or employed as an embodiment of the reservoir 180 (e.g.,
FIGS. 7 and 8C), that may be employed in the system 200 according
to various embodiments of the present invention. As previously
described, the reservoir 280 may have an interior volume 285 for
containing fluidic media. The reservoir 280 may include a septum
284 located at a port 282 of the reservoir 280. In various
embodiments, the reservoir 280 may be made of various suitable
materials, including, but not limited to, glass, plastic,
TOPAS.RTM. polymer (or any other cyclic olefin copolymer (or
polymer)), or the like. The reservoir 280 may be of any suitable
shape and/or size and may be adapted to hold any volume of fluidic
media depending on needs of user-patients.
The port 282 may be for expelling fluidic media contained in the
interior volume 285 of the reservoir 280, for example, when the
reservoir 280 is used with a delivery device (not shown) for
delivering fluidic media to a user-patient. In various embodiments,
the port 282 of the reservoir 280 may be for allowing fluidic media
to flow into the interior volume 285 of the reservoir 280 (i.e., to
fill the interior volume 285 of the reservoir 280), for example,
from the vial 240 via the needle 252 of the transfer guard 260.
Thus, in some embodiments, the port 282 may allow for filling the
reservoir 280, for example, when connected to the transfer guard
260 connected to the vial 240, and for expelling fluidic media, for
example, when connected to a delivery device.
In some embodiments, the port 282 may be near an edge of the
reservoir 280 to facilitate a purging of bubbles in the interior
volume 285 of the reservoir 280. For example, the user-patient
could tilt the reservoir 280 (or the entire system 200) slightly to
allow bubbles to escape through the port 282.
In some embodiments, an end 289 of the reservoir 280 may be open to
allow the plunger head 290 and/or at least a portion of the plunger
arm 210 to be insertable into the reservoir 280. For example, in a
case where the port 282 is located on a first end of the reservoir
280, a second end opposite the first end may be the end 289 of the
reservoir 280.
The plunger head 290 or a portion thereof may be made of Bromobutyl
rubber, silicone rubber, or any other suitable material and/or any
derivative thereof. The plunger head 290 may be locatable within
the reservoir 280 and may be moveable in an axial direction of the
reservoir 280 to expand or contract the interior volume 285 of the
reservoir 280. The plunger head 290 may be advanced within the
reservoir 280 to expel fluidic media contained in the interior
volume 285 of the reservoir 280 out the port 282 of the reservoir
280, for example, when the reservoir 280 is used with the delivery
device for delivering fluidic media to the user-patient. In various
embodiments, the plunger head 290 may be adapted to be moveable
within the reservoir 280 to draw fluidic media into the reservoir
280 from the vial 240, for example, in a case where the reservoir
280 is connected to the transfer guard 260 and the vial 240 is
connected to the transfer guard 260.
The plunger head 290 may have a front portion 297 and a rear
portion 298. The front portion 297 of the plunger head 290 may be
in contact with fluidic media contained in the interior volume 285
of the reservoir 280. In some embodiments, the front portion 297 of
the plunger head 290 may comprise a material compatible with
fluidic media contained or to be contained in the interior volume
285 of the reservoir 280.
The rear portion 298 of the plunger head 290 may be connected or
connectable to an end of the plunger arm 210 in any suitable
manner. For example, the rear portion 298 of the plunger head 290
may include at least one aperture 291 or the like for receiving at
least one tab 211 or the like of the plunger arm 210. The at least
one tab 211 may be snap-fit into the at least one aperture 291 to
connect the plunger arm 210 to the rear portion 298 of the plunger
head 290. In some embodiments, the plunger head 290 may contain at
least one tab 292 or the like and the plunger arm 210 may include
at least one aperture 212 or the like for receiving the at least
one tab 292. In various other embodiments, the plunger arm 210 may
be connected to the plunger head 290 and/or the rear portion 298 of
the plunger head 290 in any suitable manner, such as, but not
limited to, an adhesive, friction fitting, laser welding, magnetic
coupling, or the like.
The plunger arm 210 may be moveable in an axial direction within
the plunger arm casing 230 and the reservoir 280. In some
embodiments, the plunger arm 210 and the rear portion 298 of the
plunger head 290 may be integral to one another. In such
embodiments, the plunger arm 210 and the integrated rear portion
298 may be integral with the plunger head 290 or be connectable to
the plunger head 290. In other embodiments, the plunger arm 210 and
the rear portion 298 of the plunger head 290 may be separate
components adapted to be connected together as previously
described.
The plunger arm 210 may include an engagement side 218 for
operatively engaging a drive member (not shown), drive linkage, or
the like when connected to the delivery device. For example, the
engagement side 218 of the plunger arm 210 and the drive member may
be complementing gears, complementing threaded or toothed members,
or the like, that may operatively engage each other. The drive
member may be a drive screw, drive rack, or the like.
The drive member may be operatively connected to a motor to move or
otherwise actuate the drive member to actuate or otherwise cause
the plunger arm 210 to move within the plunger arm casing 230
and/or the reservoir 280. Accordingly, the plunger arm 210 may move
within the reservoir 280 to expand or contact the interior volume
285 of the reservoir 280 to fill the reservoir 280 with fluidic
media or expel fluidic media from the reservoir 280. In some
embodiments, the drive motor may be operatively engaged or directly
engaged with the engagement side 218 of the plunger arm 210 to
actuate or otherwise cause the plunger arm 210 to move within the
plunger arm casing 230 and/or the reservoir 280.
The plunger arm casing 230 may be for supporting the plunger arm
210 as the plunger arm 210 is moved along the plunger arm casing
230 and/or the reservoir 280, for example, from actuation by the
drive member or the handle 220 (e.g., FIGS. 16A-17). At least one
side of the plunger arm 210 may be in contact with one or more
interior sides of the plunger arm casing 230. In some embodiments,
the plunger arm casing 230 may be for aligning or otherwise guiding
the plunger arm 210, for example, into the reservoir 280 as the
plunger arm 210 moves along the reservoir 280, for example, from
actuation by the drive member or the handle 270 (discussed later).
The casing 230 may be made of a material of suitable strength and
durability such as, but not limited to, plastic, metal, glass
(e.g., tempered glass), composite material, and/or the like. In
some embodiments, the casing 230 may be made of the same material
as the reservoir 280.
In various embodiments, the plunger arm casing 230 may be sized and
configured to substantially or completely envelop the plunger arm
210, for example, when the plunger head 290 is drawn substantially
near the end 289 of the reservoir 280 (e.g., in a case where the
reservoir 280 has been filled or substantially filled with fluidic
media). Thus in some embodiments, the plunger arm 210 or a portion
thereof may be located within the reservoir 280 and/or the plunger
arm casing 230 during use of the system 200 for transferring
fluidic media from the vial 240 to the reservoir 280 or during
operation of the delivery device.
In some embodiments, the plunger arm casing 230 may have an opening
236 for allowing a portion of the engagement side 218 of the
plunger arm 210 to operatively engage the drive member or drive
motor. In such embodiments, the plunger arm 210 may be surrounded
by the plunger arm casing 230 and/or the reservoir 280 except for
the portion of the engagement side 218 of the plunger arm 210
exposed by the opening 236, which may be free from (i.e., not
surrounded by) the plunger arm casing 230 and/or the reservoir 280.
This may allow the drive member to operatively engage the
engagement side 218 of the plunger arm 210 while the plunger arm
210 or a portion thereof remains in the plunger arm casing 230
and/or the reservoir 280.
The system 200 may include a reservoir cover 234 that may be sized
and configured to cover the end 289 of the reservoir 280. The
reservoir cover 234 may cover the end 289 of the reservoir 280 or
be configured to fit within or to the end 289 of the reservoir 280
to seal or close the end 289 of the reservoir 280. The reservoir
cover 234 may be integral with or separate from the plunger arm
casing 230. The reservoir cover 234 may have an opening 233 (refer
to FIG. 17) to allow the plunger arm 210 to move into or out of the
reservoir 280. The reservoir cover 234 may be made of a material of
suitable strength and durability such as, but not limited to,
plastic, metal, glass (e.g., tempered glass), composite material,
and/or the like. In some embodiments, the reservoir cover 234 may
be made of the same material as the plunger arm casing 230 and/or
the reservoir 280.
In some embodiments, the reservoir cover 234 and/or the plunger arm
casing 230 may be configured for minimizing an expansion of the
reservoir 280 in one or more dimensions. In such embodiments, by
fitting the reservoir cover 234 to the end 289 of the reservoir
280, the reservoir cover 234 may help retain a shape of the
reservoir 280, for example, as the interior volume 285 of the
reservoir body 280 fills with fluidic media.
In some embodiments, the reservoir system 200 may include at least
one support flange 217 positioned on the plunger arm 210 and the
rear portion 298 of the plunger head 290. The support flange 217
may provide additional structural strength to the plunger arm 210
and/or the plunger head 290. For example, the support flange 217
may have a triangular configuration and be positioned with one side
of the support flange 217 connected to a surface of the plunger arm
210 and a second side of the support flange 217 connected to the
rear portion 298 of the plunger head 290.
In addition to or alternative to, a second support flange (not
shown) may be positioned with one side of the second support flange
connected to a different surface of the plunger arm 210 and a
second side of the second support flange connected to the rear
portion 298 of the plunger head 290. In various embodiments,
support flanges may located along any suitable location for
providing support to the plunger arm 210 and/or the plunger head
290 or any other component. One or both of the support flanges may
be made of a material of suitable strength and durability such as,
but not limited to, plastic, metal, glass (e.g., tempered glass),
composite material, and/or the like. In some embodiments, the one
or both of the support flanges may be made of the same material as
the plunger arm casing 230, the reservoir cover 234, and/or the
reservoir 280.
In some embodiments, the plunger arm casing 230 may include a
groove 238 or the like for allowing a portion of the handle 220
(e.g., FIGS. 16A-17) to operatively engage the plunger arm 210.
Thus, the handle 220 may be operatively engaged to the plunger arm
210 through the groove 238 to transfer force to actuate or
otherwise move the plunger arm 210 along the plunger arm casing 230
and/or the reservoir 280.
With reference to FIGS. 9, 10, 12, 13, and 17, in various
embodiments, the second end 270 may be connected to or integrated
with the transfer guard 260. The second end 270 may comprise a body
273. The body 273 may have a hollow interior 275 for removably
receiving at least a portion of the reservoir 280. In further
embodiments, the body 273 may be adapted such that the reservoir
280 may be placed entirely in the hollow interior 275 of the body
273. In embodiments where the port 282 is located near an edge of
the reservoir 280, the second end 270 may be off center from the
transfer guard 260. The body 273 may be made of a material of
suitable strength and durability such as, but not limited to,
plastic, metal, glass (e.g., tempered glass), composite material,
and/or the like. In some embodiments, the body 273 may be made of
the same material as the transfer guard 260 or a portion
thereof.
In some embodiments, the body 273 may include one or more fill
lines 278 or other indicators for providing information located,
for example, on a front side 273a of the body 273. In other
embodiments, the one or more fill lines 278 may be arranged in any
suitable manner or along any suitable portion of the body 273. For
instance, the one or more fill lines 278 may correspond to
amount(s) of fluidic media contained in the reservoir 280. Thus,
for example, the user-patient can fill the reservoir 280 accurately
with a specific amount (e.g., 0.5 ml, 1 ml, etc.) of fluidic media
from the vial 240 by comparing an amount of fluidic media in the
interior volume 285 of the reservoir 280 with the one or more fill
lines 278.
In some embodiments, an indicator 279 may be provided corresponding
to a location of the port 282 of the reservoir 280 in a case where
the reservoir is mated with the second end 270. In such
embodiments, the user-patient can direct bubbles in the interior
volume 285 of the reservoir 280 toward the indicator, for example
by titling the reservoir 280 or the system 200, to purge the
bubbles.
In further embodiments, the body 273 may be adapted to allow a
user-patient to view at least some contents in the reservoir 280.
For example, portions of the body 273 may have an opening to expose
at least a portion of the reservoir 280 within the hollow interior
275 of the body 273. In such embodiments, the user-patient may be
able to hold the reservoir though the opening to further support
the reservoir 280 during use of the system 200. As another example,
the body 273 or portions thereof may be at least partially
transparent to visually expose at least a portion of the reservoir
280 within the hollow interior 275 of the body 273.
In some embodiments, the body 273 may be configured to secure the
reservoir 280 or a portion thereof in the hollow interior 275 once
the reservoir 280 is placed in the hollow interior 275. For
example, the body 273 may have one or more tabs 277 or the like
within the hollow interior 275 for securing or otherwise preventing
accidental removal of the reservoir 280 from the hollow interior
275.
In some embodiments, the body 273 may be adapted to be flexible.
This may allow, for example, the user-patient to squeeze at least a
portion of the body 273, such as, but not limited to, along one or
more sides 273b of the body 270 to release the one or more tabs 277
to allow the reservoir 280 to be inserted into or removed from the
hollow interior 275.
With reference to FIGS. 13-14B, in various embodiments, the
transfer guard 260 may include a body 265. The first needle 252 may
be arranged to pass through the body 265 to provide a fluid flow
path between the vial 240 and the reservoir 280. In some
embodiments, the body 265 may be formed by connecting the first end
262 and the second end 270 together (e.g., FIG. 13). In other
embodiments, the body 265, the first end 262, and the second end
270 may be integral with each other (e.g., FIG. 14C).
In some embodiments, the transfer guard 260 may include an inner
body 250 located within the body 265. In such embodiments, the
first needle 252 may be arranged to pass through the body 265 and
the inner body 250. The inner body 250 may be made of a material of
suitable strength and durability such as, but not limited to,
plastic, metal, glass (e.g., tempered glass), composite material,
and/or the like. In some embodiments, the inner body 250 may be
made of the same material as the body 273 and/or the transfer guard
260 or a portion thereof. The inner body 250 may be separate from
or integrated with the body 265 of the transfer guard 260.
The first needle 252 may have a first end 252a (and/or opening
along the first needle 252) and a second end 252b (and/or opening
along the first needle 252) opposite each other. The first end 252a
may be for arrangement in the vial 240, for example, in contact
with fluidic media in the interior volume 245 or the headspace 247
of the vial 240 in a case where the vial 240 is connected to the
transfer guard 260. The second end 252b may be for arrangement in
the reservoir 280, for example, through the septum 284 into the
port 282 of the reservoir 280. In some embodiments, one or more of
the ends 252a, 252b of the first needle 252 may be beveled to
provide one or more sharp ends to the first needle 252. In other
embodiments, one or more of the ends 252a, 252b of the first needle
252 may be flat.
The second needle 256 may have a first end 256a (and/or opening
along the second needle 256) and a second end 256b (and/or opening
along the second needle 256) opposite each other. The first end
256a may be for arrangement in the vial 240, for example, in
contact with fluidic media in the interior volume 245 or a
headspace (e.g., 147 in FIG. 7) of the vial 240 in a case where the
vial 240 is connected to the transfer guard 260. The second end
256b may be arranged in the transfer guard 260 or external to the
transfer guard 260. In some embodiments, one or more of the ends
256a, 256b of the second needle 256 may be flat. In other
embodiments, one or more of the ends 256a, 256b of the second
needle 256 may be beveled to provide one or more sharp ends to the
second needle 256.
In some embodiments, the inner body 250 may have a chamber 253. In
further embodiments, the transfer guard 260 may include a mechanism
to allow air to flow in one direction, such as, a valve 255 or a
membrane, arranged within the chamber 253. The valve 255 may be,
but is not limited to, an umbrella valve, duckbill valve, ball
check valve, or the like.
The second end 256b of the second needle 256 may be in
communication with the chamber 253. The valve 255 may regulate flow
of air into and/or out of the interior volume 245 of the vial 240
through the second needle 256. Thus, the valve 255 may allow for
equalizing pressure within the interior volume 245 of the vial 240,
for example, relative to atmosphere to facilitate transfer of
fluidic media from the vial 240 to the reservoir 280. In yet
further embodiments, the valve 255 may be provided with a seal
member 259 to prevent fluidic media from flowing past the seal
member 259 and/or to facilitate movement of the valve 255 in the
chamber 253. In some embodiments, one or more retaining members,
such as ridge 251, or the like, may be for retaining the valve 255
within the chamber 253.
In some embodiments, the valve 255 may have a channel 257 to allow
the chamber 253 to communicate with atmosphere, for example, to
allow air to flow into or out of the chamber 253. In some
embodiments, the valve 255 may substantially prevent liquid from
coming out of the vial 240 through the second needle 256 and/or the
valve 255. In various embodiments, the second needle 256 may allow
for venting the headspace or the interior volume 245 of the vial
240 to atmosphere to facilitate the transfer of fluidic media from
the vial 240 to the reservoir 280. Thus, in such embodiments, the
valve 255 may allow pressure within the vial to be equalized or
otherwise regulated to facilitate the transfer of fluidic media
from the vial 240 to the reservoir 280.
In some embodiments, such as the embodiment exemplified in FIG.
14C, the system 200 may employ a transfer guard 260', which may
include features similar to the transfer guard 260 (e.g., 9-14B).
The transfer guard 260' may include a body 265'. A first needle
252' may be arranged to pass through the body 265' to provide a
fluid flow path between the vial 240 and the reservoir 280. In some
embodiments, the body 265' may be formed by connecting the first
end 262 and the second end 270 together (e.g., FIG. 13). In other
embodiments, the body 265', the first end 262, and the second end
270 may be integral with each other (e.g., FIG. 14C).
The first needle 252' may have a first end 252a' (and/or opening
along the first needle 252') and a second end 252b' (and/or opening
along the first needle 252') opposite each other. The first end
252a' may be for arrangement in the vial 240, for example, in
contact with fluidic media in the interior volume 245 or the
headspace 247 of the vial 240 in a case where the vial 240 is
connected to the transfer guard 260'. The second end 252b' may be
for arrangement in the reservoir 280, for example, through the
septum 284 into the port 282 of the reservoir 280. In some
embodiments, one or more of the ends 252a', 252b' of the first
needle 252' may be beveled to provide one or more sharp ends to the
first needle 252'. In other embodiments, one or more of the ends
252a', 252b' of the first needle 252' may be flat.
At least a portion of the first needle 252' may be arranged within
at least a portion of a second needle 256'. In some embodiments,
the first needle 252' (or at least a portion thereof) may be
concentrically arranged within the second needle 256' (or at least
a portion thereof). Thus in various embodiments, the first needle
252' and the second needle 256' may share a common axis. In other
embodiments, the first needle 252' (or at least a portion thereof)
may be concentrically arranged within the second needle 256' (or at
least a portion thereof) such that the first needle 252' is offset
from the second needle 256' with a spacing 258. Thus in various
embodiments, the first needle 252' and the second needle 256' each
have their own axis parallel to each other.
In some embodiments, the transfer guard 260' may have a chamber
253'. The chamber 253' may be in communication with the interior
volume 245 of the vial 240, for example, through the second needle
256'. For instance, one end 256a' (and/or opening) of the second
needle 256' may be in communication with the interior volume 245 of
the vial 240, and another end 256b' (and/or opening), opposite the
end 256a', may be in communication with the chamber 253'. In some
embodiments, one or more of the ends 256a', 256b' of the second
needle 256' may be flat. In other embodiments, one or more of the
ends 256a', 256b' of the second needle 256' may be beveled to
provide one or more sharp ends to the second needle 256'.
In further embodiments, the transfer guard 260' may include a
mechanism to allow air to flow in one direction, such as, a valve
255' or a membrane, arranged within the chamber 253'. The valve
255' may be, but is not limited to, an umbrella valve, duckbill
valve, ball check valve, or the like.
The valve 255' may regulate flow of air into and/or out of the
interior volume 245 of the vial 240 through the needle 254'. Thus,
the valve 255' may allow for equalizing pressure within the
interior volume 245 of the vial 240, for example, relative to
atmosphere to facilitate transfer of fluidic media from the vial
240 to the reservoir 280. In yet further embodiments, the valve
255' may be provided with a seal member (e.g., 259 in FIG. 14B) to
prevent fluidic media from flowing past the seal member and/or to
facilitate movement of the valve 255' in the chamber 253'. In some
embodiments, one or more retaining members, such as ridge (e.g.,
251 in FIG. 14B), or the like, may be for retaining the valve 255'
within the chamber 253'.
In some embodiments, the valve 255' may have a channel 257' to
allow the chamber 253' to communicate with atmosphere, for example,
to allow air to flow into or out of the chamber 253'. In some
embodiments, the valve 255' may substantially prevent liquid from
coming out of the vial 240. In various embodiments, the second
needle 256' may allow for venting a headspace (e.g., 147 in FIG. 7)
or the interior volume 245 of the vial 240 to atmosphere to
facilitate the transfer of fluidic media from the vial 240 to the
reservoir 280. Thus, in such embodiments, the valve 255' may allow
pressure within the vial to be equalized or otherwise regulated to
facilitate the transfer of fluidic media from the vial 240 to the
reservoir 280.
Accordingly, in various embodiments, a second needle for equalizing
pressure within a vial or to otherwise regulate or facilitate the
transfer of fluidic media from the vial to a reservoir may be
concentrically arranged around a first needle for transferring the
fluidic media from the vial to the reservoir.
Referring to FIGS. 10 and 15 to operate the system 200, in step
S1010, the vial 240 and the reservoir 280 may be attached or
otherwise mated with the first end 262 and the second end 270 of
the transfer guard 260 respectively. Then in step S1020, the
plunger head 290 may be inserted into the reservoir 280. Next in
step S1030, the plunger arm 210 may be connected to the plunger
head 290 (if not integrated or already connected). In step S1040,
the plunger arm casing 230 and reservoir cover 234 may be arranged
to support the plunger arm 210 and cover the reservoir 280. Then in
step S1050, the handle 220 may be operatively connected to the
plunger arm 210 as shown in FIG. 9.
With reference to FIGS. 9, 10, and 16A-17, the handle 220 may be
for operatively connecting to or otherwise engaging the plunger arm
210 to actuate or otherwise cause movement of the plunger arm 210
by advancing or withdrawing the handle 220 along line A. Because
the plunger head 290 may be attached to the plunger arm 210,
movement of the handle 220 may advance or draw the plunger head 290
within the reservoir 280. Accordingly, fluidic media may be drawn
from the vial 240 into the reservoir 280 by drawing the handle 290
and the operatively engaged plunger arm 210 and plunger head 290,
for example, away from the reservoir 280.
The handle 220 may have a body 224 that may be sized and configured
to cover at least a portion of the plunger arm casing 230. The body
224 may have an interior cavity 223 for receiving at least a
portion of the plunger arm casing 230 within the interior cavity
223 through an opening 223a. The body 224 may be for supporting the
plunger arm casing 230, for example, as the plunger arm 210 is
moved along the plunger arm casing 230 and/or the reservoir 280.
The body 224 may be made of a material of suitable strength and
durability such as, but not limited to, plastic, metal, glass
(e.g., tempered glass), composite material, and/or the like. In
some embodiments, the body 224 may be made of the same material as
the plunger arm casing 230.
At least one side of the plunger arm casing 230 may be in contact
with one or more interior sides of the body 224. In some
embodiments, the body 224 may be for aligning the plunger arm
casing 230 when the plunger arm casing 230 is placed within the
interior cavity 223 of the body 224. In various embodiments, the
plunger arm casing 230 may remain substantially still as the handle
220 actuates the plunger arm 210 along the plunger arm casing 230
and/or the reservoir 280.
The handle 220 may be configured to operatively engage and
disengage the plunger arm 210 and/or the plunger arm casing 230 in
any suitable manner. In some embodiments, the handle 220 may have
an engagement portion 226 for operatively engaging and disengaging
the plunger arm 210. Accordingly, movement of the handle 220 may
actuate the plunger arm 210 and therefore the plunger head 290
attached to the plunger arm 210 to allow fluidic media to be drawn
from the vial 240 to the reservoir 280 via the first needle 252.
The engagement portion 226 may have a first end 226a and a second
end 226b.
In some embodiments, a movable member, such as a slide 225, may be
mounted on the engagement portion 226 and may be moveable at least
between the first end 226a and the second end 226b to lock and
unlock the handle 220 to the plunger arm 210. The first end 226a
and the second end 226b may be for preventing the slide 225 from
being dismantled accidentally from the engagement portion 226. In
some embodiments, the engagement portion 226 may include a rail 228
or the like for allowing the slide 225 to slide or otherwise move
at least between the first end 226a and the second end 226b.
In other embodiments, the moveable member may be a rotatable member
(not shown). The rotatable member may be moveable (e.g., rotatable)
at least between the first end 226a and the second end 226b to lock
and unlock the handle 220 to the plunger arm 210. For example, the
rotatable member may be rotatable about an axis of the handle 220.
In other embodiments, the moveable member may be a hinged member
(not shown) for locking and unlocking the handle 220 to the plunger
arm 210.
In some embodiments, the engagement portion 226 may be pivotally
mounted, cantilevered, biased, or otherwise positioned relative to
the body 224 of the handle 220. In such embodiments, the engagement
portion 226 may be adapted for pivotal movement about a pivot point
226c. The engagement portion 226 may include a member, such as a
finger 227 or the like, for engaging an aperture 211 or the like in
the plunger arm 210. Accordingly, the finger 227 may be pivotable
or otherwise moveable toward and away from the body 224 as the
engagement portion 226 is pivoted about the pivot point 226c to
engage and disengage the plunger arm 210.
In further embodiments, the engagement portion 226 may be pivoted
about the pivot point 226c by movement of the slide 225. For
example, by moving the slide 225 toward the second end 226b (e.g.,
FIG. 16A), a front portion of the engagement portion 226, which may
include the finger 227, may pivot upward. Accordingly, the plunger
arm casing 230 having the plunger arm 210 within may be placed at
least partially in the interior cavity 223 of the body 224. Then by
moving the slide 225 toward the first end 226a (e.g., FIG. 9), the
front portion of the engagement portion 226 and the finger 227 may
pivot downward to allow the finger 227 to engage the aperture 211
in the plunger arm 210, for example, through the groove 238 in the
plunge arm casing 230. The finger 227 may remain engaged in the
aperture 211 while the slide 225 remains at or near the first end
226a.
Once engaged, the handle 220 may be drawn away from the reservoir
240 to draw fluidic media from the vial 240 through the first
needle 252 of the transfer guard 260 to the reservoir 280. After
the reservoir 280 is sufficiently filled with a desired amount of
fluidic media, the slide 225 may be moved toward the second end
226b to allow the front portion of the engagement portion 226 and
the finger 227 to pivot upward to disengage the plunger arm 210.
Accordingly, the user-patient may remove the reservoir 280, the
plunger arm 210, and/or the plunger arm casing 230 and insert the
appropriate components in the delivery device (not shown) or
provide another reservoir, plunger arm, and/or plunger arm casing
in the system 200.
The handle 220 may include a base 222. The base 222 may be for
standing the system 200 vertically on a support surface. In some
embodiments, the base 222 may include an adhesive or the like for
securing the handle 220 to the support surface. Thus in some
embodiments, in a case where the base 222 of the system 200 on a
support surface and fluidic media is to be drawn from the vial 240
to the reservoir 280, the reservoir 280 (along with the transfer
guard 260 and the vial 240) may be drawn away from the handle 220,
which may remain substantially still, to transfer fluidic media. In
some embodiments, the base 222 may be for providing the
user-patient with a gripping area to use the system 200, for
example, to pull the handle 220 to draw fluidic media into the
reservoir 200.
Referring to FIGS. 9, 13, and 15, various embodiments of the system
200 may allow for simplifying a filling process of the reservoir
280 with fluidic media from the vial 240. After step S1050, the
handle 220 operatively engaged with the plunger arm 210 may be
pulled or otherwise moved away from the reservoir 280. As the
handle 220 moves away from the reservoir 280, the attached plunger
arm 210 and plunger head 290 may be moved within the reservoir 280
to increase the interior volume 285 of the reservoir 280. The
movement of the plunger head 290 may draw fluidic media from the
vial 240 through the first needle 252 of the transfer guard 260 to
the interior volume 285 of the reservoir 280 to transfer fluidic
media to the reservoir 280.
With reference to FIGS. 9-17, in various embodiments, the steps of
the process 1000 may be performed in any suitable order. For
example, the vial 240 may be attached to the transfer guard 260
after the handle 220 is operatively engaged with the plunger arm
210. As another example, the plunger arm 210 may be connected to
the plunger head 290 before the plunger head 290 is placed in the
reservoir 280. In some embodiments, the plunger head 290 may be
advanced within the reservoir 280 toward the port 282 of the
reservoir 280 before starting the filling process of the reservoir
280, for example, to prime the system 200.
The system 200 may be used to fill the interior volume 285 of the
reservoir 280, or a portion thereof. In some embodiments, the
system 200 may be configured such that the interior volume 285 of
the reservoir 280 is completely filled or sufficiently filled when
the handle 290 is drawn as far from the reservoir 280 as the system
allows.
The embodiments disclosed herein are to be considered in all
respects as illustrative, and not restrictive of the invention. The
present invention is in no way limited to the embodiments described
above. Various modifications and changes may be made to the
embodiments without departing from the spirit and scope of the
invention. The scope of the invention is indicated by the attached
claims, rather than the embodiments. Various modifications and
changes that come within the meaning and range of equivalency of
the claims are intended to be within the scope of the
invention.
* * * * *